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5789-98

by Zimmer, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024439740 UDI-DI Date16 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
5789-98, 00-5789-098-00
Primary DI / UDI-DI
00889024439740
FDA product code
FSM
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Overview

AI-generated summary, 9 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

5789-98 is a Tray, Surgical, Instrument classified as a Device sterilization/disinfection container, reusable. This device is designed to hold wrapped and/or unwrapped medical/dental devices during washing/disinfection and sterilization cycles. The model number is 5789-98 and the catalog number is 00-5789-098-00.

The device requires sterilization prior to use using Moist Heat or Steam Sterilization methods. It is classified as Class I under FDA regulation number 878.4800 with product code FSM. The device is currently in commercial distribution and is prescription use only.

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Questions

AI-generated answers, 9 Nov 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the 5789-98?

    It is recorded under the GMDN device type "Device sterilization/disinfection container, reusable", which GMDN defines as "A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s)". FDA lists it under the product name "Tray, Surgical, Instrument". It is recorded as Class I.

  • What are the product code and regulation of the 5789-98?

    FDA records the 5789-98 under product code FSM and regulation number 878.4800.

  • Who makes the 5789-98?

    Zimmer, Inc. is the manufacturer on record for the 5789-98.

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)